Assemblies for use with an endoscope

ABSTRACT

Mounting a double-balloon auxiliary endoscope assembly over a conventional endoscope by sliding an overtube subassembly over the conventional endoscope, and thereafter sliding over the conventional endoscope, while connected to the overtube subassembly via a flexible interconnection tube, a forward balloon support sleeve of a forward balloon subassembly also including a forward balloon fixedly mounted on the forward balloon support sleeve and defining together therewith a forward inflatable volume.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/811,003, filed Jul. 28, 2015, entitled “ASSEMBLIES FOR USE WITH ANENDOSCOPE,” which is a divisional of U.S. patent application Ser. No.12/934,775, filed Dec. 10, 2010, now U.S. Pat. No. 9,119,532, issuedSep. 1, 2015, entitled “ASSEMBLIES FOR USE WITH AN ENDOSCOPE,” which isa National Phase Application of PCT Application No. PCT/IL2009/000322,filed Mar. 23, 2009, which claims priority form U.S. Provisional PatentApplication Ser. No. 61/064,881, filed Mar. 31, 2008, entitled “DEVICEAND METHOD FOR EXPANDABLE ELEMENT,” the disclosure of which is herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates to endoscope systems generally.

BACKGROUND OF THE INVENTION

The following patent publications and commercially available productsare believed to represent the current state of the art:

U.S. Pat. Nos. 4,040,413; 4,148,307; 4,195,637; 4,453,545; 4,676,228;4,862,874; 5,025,778; 6,007,482; 6,309,346; 6,461,294; 6,585,639;

U.S. Patent Application publication Nos. 2004/0102681; 2005/0124856;2005/0125005; 2005/0137457; 2005/0165273; 2006/0111610; 2006/0161044 and2007/0244361;

Double Balloon Endoscope product, including EN-450T5 enteroscope,TS-13140 overtube and BS-2 front balloon, which interface with balloonpump control BP-20 and 2200 video system, all commercially availablefrom Fujinon Inc., of 10 High Point Drive, Wayne, N.J., USA; and

Sleeve Expander Tool product, manufactured by HellermannTyton of 7930 N.Faulkner Road., Milwaukee, Wis. USA, and commercially distributed in theUK by Canford Audio PLC of Crowther Road, Washington, UK under catalognumber 55-601.

SUMMARY OF THE INVENTION

The present invention seeks to provide improved assemblies for operationwith elongate articles such as endoscopes.

There is thus provided in accordance with a preferred embodiment of thepresent invention an expander for mounting a resilient outer tubulararticle over an elongate article including a chassis element havingassociated therewith at least one outwardly movable element which isselectably engageable with at least a portion of the resilient outertubular article, a driver which is movable with respect to the chassiselement and is operative to selectably engage the at least one outwardlymovable element, when the outwardly movable element is in engagementwith the at least a portion of the resilient outer tubular article, forproducing corresponding outward motion and outward expansion thereof andan engagement element, associated with the driver, for insertion intothe at least a portion of the resilient outer tubular article uponexpansion thereof by operation of the driver, the engagement elementbeing configured to accommodate at least a portion of the elongatearticle.

In accordance with a preferred embodiment of the present invention theexpander also includes resilient outer tubular article disengagementfunctionality operative for disengagement of the at least a portion ofthe resilient outer tubular article from the engagement element.Preferably, the disengagement functionality is associated with thechassis element. Additionally or alternatively, the disengagementfunctionality is operative for sliding the at least a portion of theresilient outer tubular article relative to the engagement element.

Preferably, the expander is operative for mounting the resilient outertubular article over the elongate article at a generally predetermineddistance from a forward end thereof. Additionally or alternatively, theengagement element is removably associated with the driver. Additionallyor alternatively, the engagement element is adapted for accommodatingthe at least a portion of the elongate article up to a predeterminedlength thereof. Preferably, the engagement element is generally smallerthen the chassis element. Yet preferably, the driver is axially movablewith respect to the chassis element.

There is also provided in accordance with another preferred embodimentof the present invention a method for mounting a resilient outer tubulararticle over an elongate article including employing an expander whichincludes a chassis element which is selectably engageable with at leastone resilient portion of the resilient outer tubular article, a driverwhich is movable with respect to the chassis, and an engagement elementconfigured to accommodate at least a portion of the elongate article, tocarry out the functions of expanding the at least one resilient portionof the resilient outer tubular article, followed by insertion of theengagement element into the at least one resilient portion, followed byengagement of the elongate article with the engagement element, followedby disengagement of the engagement element from the at least oneresilient portion.

In accordance with a preferred embodiment of the present invention, themethod of mounting a resilient outer tubular article over an elongatearticle also includes, following the insertion of the engagement elementinto the at least one resilient portion, and prior to engagement of theelongate article with the engagement element, the step of disengagementof the engagement element from the remainder of the expander.Additionally or alternatively, the method also includes following theengagement of the elongate article with the engagement element, andprior to the disengagement of the engagement element from the at leastone resilient portion, the step of engagement of the engagement elementwith the remainder of the expander. Additionally or alternatively, thedisengagement of the engagement element from the at least one resilientportion includes sliding the engagement element relative to the at leastone resilient portion.

There is further provided in accordance with yet another preferredembodiment of the present invention a hand-held collar cutting tool forremoval of an auxiliary endoscope assembly having a resilient collarportion from an endoscope, the cutting tool including a hand-held collarcutting tool body portion, a cutting edge associated with the cuttingtool body portion and adapted for cutting the resilient collar portion,and a spacer portion protruding from the hand-held collar cutting toolbody portion, the spacer portion being adapted for insertion between theresilient collar portion and the endoscope for spacing the endoscopefrom the resilient collar portion and from the cutting edge.

In accordance with a preferred embodiment of the present invention, thespacer portion has an elongate, tapered shape. Preferably, the spacerportion has varied flexibility along its length. Additionally oralternatively, the spacer portion is softer than an external surface ofthe endoscope.

There is also provided in accordance with still another preferredembodiment of the present invention a method for removal of an auxiliaryendoscope assembly having a resilient collar portion from an endoscopeincluding employing a hand-held collar cutting tool having a spacerportion and a cutting edge to perform the sequential functions ofinserting the spacer portion between the resilient collar portion andthe endoscope, thereby spacing the resilient collar portion from theendoscope and spacing the endoscope from the cutting edge, and bringingthe cutting edge into cutting engagement with the resilient collarportion when the resilient collar portion and the cutting edge are bothspaced from the endoscope, thereby to prevent cutting damage to theendoscope.

There is even further provided in accordance with still anotherpreferred embodiment of the present invention a double-balloon auxiliaryendoscope assembly suitable for use with a conventional endoscope, theassembly including a forward balloon subassembly including a forwardballoon support sleeve arranged for mounting in a fixed position overthe conventional endoscope and having a forward balloon support sleevemounted, forward balloon inflation lumen extending at least partiallyalong the forward balloon support sleeve, and a forward balloon mountedon the forward balloon support sleeve and together therewith defining aforward inflatable volume which is inflatable via the forward balloonsupport sleeve mounted, forward balloon inflation lumen, an overtubesubassembly including an overtube sleeve arranged for slidable mountingover the conventional endoscope, and an overtube balloon mounted on theovertube sleeve and together therewith defining a rearward inflatablevolume, and the overtube sleeve having first and second lumens extendingat least partially therealong, the first lumen being an overtubemounted, forward balloon inflation lumen, and the second lumen being anovertube mounted, overtube balloon inflation lumen, the rearwardinflatable volume being inflatable via the overtube mounted, overtubeballoon inflation lumen, and an overtube rearward displacementaccommodating, flexible interconnection tube interconnecting the forwardballoon support sleeve mounted, forward balloon inflation lumen and theovertube mounted, forward balloon inflation lumen.

Preferably, the interconnection tube is selectably extendible by beingat least partially straightened. Additionally or alternatively, thedouble-balloon auxiliary endoscope assembly also includes a forwardballoon inflation/deflation supply and exhaust tube connected to thefirst lumen and an overtube balloon inflation/deflation supply andexhaust tube connected to the second lumen. Additionally oralternatively, the forward balloon support sleeve includes a resilientcollar. Preferably, the forward balloon support sleeve includes a collarwhich is adapted to fixedly mount the forward balloon support sleeveonto endoscopes of varying outer diameter.

There is also provided in accordance with another preferred embodimentof the present invention a method for mounting a double-balloonauxiliary endoscope assembly over a conventional endoscope, the methodincluding sliding an overtube subassembly over the conventionalendoscope, and thereafter sliding over the conventional endoscope, whileconnected to the overtube subassembly via a flexible interconnectiontube, a forward balloon support sleeve of a forward balloon subassemblyalso including a forward balloon fixedly mounted on the forward balloonsupport sleeve and defining together therewith a forward inflatablevolume.

In accordance with a preferred embodiment of the present invention, themethod for mounting a double-balloon auxiliary endoscope assembly over aconventional endoscope also includes fixedly and removably mounting theforward balloon support sleeve onto the conventional endoscope.Additionally or alternatively, the method also includes initiallystretching and then releasing a resilient collar associated with theforward balloon support sleeve for fixedly and removably mounting of theforward balloon support sleeve onto the conventional endoscope.

There is further provided in accordance with yet another embodiment ofthe present invention a wrap-around overtube which is side-mountableonto an endoscope without access to an end of the endoscope, theovertube including a generally cylindrical sleeve having relatively highaxial rigidity and relatively low radial rigidity, the tube being formedwith an expandable generally axial slit, the sleeve being configured topermit circumferential expansion of the slit to an extent sufficient toaccommodate an endoscope and subsequent circumferential contraction ofthe slit to provide wrap-around mounting of the overtube onto theendoscope.

Preferably, the sleeve is configured with respect to the endoscope topermit slidable axial displacement of the sleeve along the endoscope.Additionally or alternatively, the wrap-around overtube also includes awrap-around balloon mounted over at least a portion of the sleeve, thewrap-around balloon being configured for wrap-around mounting thereofonto the endoscope. Additionally or alternatively, the wrap-aroundovertube also includes an external tube extending at least partiallyalong the sleeve, the external tube being configured for passage of anendoscope tool therethrough. Preferably, the external tube traverses theballoon. Yet preferably, the external tube includes a low-friction lumenthrough which the endoscope tool is slidably movable.

There is further provided in accordance with still another preferredembodiment of the present invention a method for mounting an overtubeonto an endoscope without access to an end of the endoscope, the methodincluding providing a wrap-around overtube having an expandablegenerally axial slit, expanding the generally axial slit so as toaccommodate the endoscope at a location spaced from an end thereof,placing the overtube, with the generally axial slit expanded, over theendoscope at a location spaced from an end thereof, and at leastpartially closing the generally axial slit thereby to retain theovertube over the endoscope at the location spaced from the end thereof.

Preferably, the method also includes sliding displacement of theovertube along the endoscope following at least partially closing of thegenerally axial slit.

There is even further provided in accordance with still anotherpreferred embodiment of the present invention a wrap-around balloonwhich is side-mountable onto an endoscope without access to an end ofthe endoscope, the wrap-around balloon including a generally cylindricalballoon being formed with an expandable generally axial slit, theballoon being configured to permit circumferential expansion of the slitto an extent sufficient to accommodate an endoscope and subsequentcircumferential contraction of the slit to provide wrap-around mountingof the balloon onto the endoscope.

There is also provided in accordance with yet another preferredembodiment of the present invention a method for mounting a balloon ontoan endoscope without access to an end of the endoscope, the methodincluding providing a wrap-around balloon, placing the wrap-aroundballoon over the endoscope at a location spaced from an end thereof, andretaining the wrap-around balloon over the endoscope.

There is further provided in accordance with still another preferredembodiment of the present invention a slidable external tube assemblyfor use with an endoscope, including an elongate tube having a lumen,the lumen being configured for passage therethrough of an endoscopetool, and at least one side-mountable element configured for removablyand slidably mounting the elongate tube onto the endoscope withoutrequiring access to an end of the endoscope.

Preferably, the elongate tube and the at least one side-mountableelement are integrally formed as one piece.

There is also provided in accordance with another preferred embodimentof the present invention a method for slidable mounting of an externaltube assembly onto an endoscope, including providing an elongate tubehaving a lumen, the lumen being configured for passage therethrough ofan endoscope tool, employing at least one side mountable element forremovably and slidably mounting the elongate tube onto the endoscopewithout requiring access to an end of the endoscope, and sliding theelongate tube axially relative to the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated from thefollowing detailed description, taken in conjunction with the drawingsin which:

FIG. 1 is a simplified assembled view illustration of a device formounting an auxiliary endoscope assembly onto an endoscope, constructedand operative in accordance with a preferred embodiment of the presentinvention;

FIG. 2 is a simplified exploded view illustration of the device formounting an auxiliary endoscope assembly onto an endoscope of FIG. 1;

FIGS. 3A, 3B, 3C and 3D are simplified illustrations of a driverassembly forming part of the device of FIGS. 1 & 2;

FIGS. 4A, 4B, 4C, 4D and 4E are simplified illustrations of a flangeelement forming part of the device of FIGS. 1 & 2;

FIGS. 5A, 5B and 5C are simplified illustrations of an arm elementforming part of the device of FIGS. 1 & 2;

FIGS. 6A, 6B, 6C, 6D, 6E and 6F are simplified illustrations of anaxially driven collar engagement element forming part of the device ofFIGS. 1 & 2;

FIGS. 7A, 7B, 7C, 7D, 7E, 7F, 7G, 7H, 7I, 7J, 7K, 7L, 7M, 7N, 7O, 7P and7Q are simplified illustrations of various stages in the operation ofthe device of FIGS. 1 & 2 for mounting an auxiliary endoscope assemblyonto an endoscope, and of various stages in the operation of a collarcutting tool for cutting a collar of an auxiliary endoscope assemblymounted on an endoscope;

FIGS. 8A, 8B, 8C, 8D, 8E, 8F, 8G, 8H, 8I, 8J, 8K, 8L, 8M, 8N, 8O and 8Pare sectional illustrations, taken along lines VIII-VIII in FIGS. 1 and7A-7P, in corresponding FIGS. 7A-7P;

FIG. 9 is a simplified, partially cut away, pictorial illustration or adouble balloon device, constructed and operative in accordance with apreferred embodiment of the present invention, which is suitable formounting on a conventional endoscope;

FIG. 10 is a simplified pictorial illustration of the double balloondevice of FIG. 9, mounted on a conventional endoscope assembly;

FIGS. 11A and 11B are simplified pictorial illustrations of an endoscopeovertube constructed and operative in accordance with a preferredembodiment of the present invention in respective open and closedorientations;

FIG. 12 is a simplified exploded pictorial illustration of the endoscopeovertube of FIGS. 11A & 11B;

FIGS. 13A, 13B and 13C are respective simplified pictorial, end view andside view illustrations of a balloon employed in the endoscope overtubeof FIGS. 11A-12; and

FIGS. 14A, 14B, 14C, 14D and 14E are simplified illustrations ofassociation of the endoscope overtube of FIGS. 11A-12 with aconventional endoscope and a conventional endoscope tool;

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is now made to FIGS. 1-6F, which illustrate a device 100 formounting an auxiliary device, having a resilient, expandable collarportion, such as an auxiliary endoscope assembly (shown in FIGS. 7A-8P)onto an endoscope (shown in FIGS. 7J-7L, 7O-7Q, and 8J-8P), constructedand operative in accordance with a preferred embodiment of the presentinvention.

The terms “endoscope” and “endoscopy” are used throughout in a mannersomewhat broader than their customary meaning and refer to apparatus andmethods which operate within body cavities, passageways and the like,such as, for example, the small intestine, the large intestine, arteriesand veins. Although these terms normally refer to visual inspection, asused herein they are not limited to applications which employ visualinspection and refer as well to apparatus, systems and methods whichneed not necessarily involve visual inspection.

Referring generally to FIGS. 1 and 2, it is seen that device 100preferably comprises a chassis element, such as a hand-engageableelement 102 (FIGS. 4A-4E) which is generally symmetric about alongitudinal axis 104. A driver assembly 106 (FIGS. 3A-3D) is arrangedfor hand-driven displacement relative to element 102 along longitudinalaxis 104.

Four arm elements 108 are individually pivotably mounted onto element102 as by respective pins 110 for selectable pivotable displacement intoand partially out of respective radially and axially extending slots 112formed in element 102 and generally symmetrically distributed aboutlongitudinal axis 104.

Springs 114 are disposed in respective slots 112 and engage respectivearm elements 108 to urge the arm elements 108 radially outwardly.Springs 114 are preferably mounted on respective pins 116 and arelocated in respective cut outs 118 formed in each of arm elements 108.An axially driven collar engagement element 120 is removably mountedonto a forward end of driver assembly 106. A rotation preventing pin 122engages an axially extending slot 124 in driver assembly 106 to preventrotation of collar engagement element 120 relative to element 102 aboutaxis 104.

As seen particularly in FIGS. 3A-3D, driver assembly 106 preferablycomprises a generally cylindrical rod portion 130 in which is axiallyextending slot 124 is formed. At a rear end of generally cylindrical rodportion 130 there is preferably provided a hand engagement portion 132,such as a disc. At a forward end of generally cylindrical rod portion130 there is preferably formed a quick release connector portion 134which is generally planar and extends in a plane perpendicular tolongitudinal axis 104 and has a cut out 136 having an edge surface 138.Disposed partially within and normally extending axially forward ofconnector portion 134 along axis 104 is a spring loaded ball engagementassembly 140, such as a spring loaded ball assembly productGN-614.3-4-NI, commercially available from ELESA-GANTER of 3 Triberger,Furtwangen, Germany.

Reference is now additionally made to FIGS. 4A-4E, which illustrate thehand-engageable element 102. The hand engageable element 102 preferablycomprises an integrally formed generally circularly symmetric body,preferably formed of a molded or machined rigid plastic or metal, suchas DELRIN® or stainless steel, including a generally cylindrical forwardportion 150 having a forward-facing generally circular edge 152.Rearward of forward portion 150 there is preferably provided a forwardgenerally conical transition portion 154 having a rearwardly increasingouter diameter.

Rearward of portion 154 there is preferably formed a main cylindricalportion 156, followed by a rearward generally conical transition portion158 having an rearwardly increasing outer diameter. Rearward of portion158 there is preferably formed a rearward cylindrical portion 160 havinga rearward facing bulkhead surface 162. Rearward of portion 160 there ispreferably formed a relatively narrow cylindrical portion 164 whichterminates in a winged generally planar end portion 166 havingforward-facing wing surfaces 168 and a rearward-facing surface 170.

Extending axially entirely through portions 166, 164, 160 and part ofportion 158 of hand-engageable element 102 along longitudinal axis 104is a relatively narrow generally circular cylindrical bore 180, which issized to slidably accommodate and guide generally cylindrical rodportion 130 in its axial displacement relative to hand-engageableelement 102.

Forwardly of cylindrical bore 180 there is formed in part of portion 158and in portions 156, 154 and 150 of hand-engageable element 102 arelatively wide generally circular cylindrical bore 182 which definesthe inner diameter of forward-facing generally circular edge 152.

Axially extending slots 112 are seen to extend in mutually adjacent 90degree relative orientations forward from a location in portion 164slightly rearwardly of surface 162, forwardly through portions 160, 158,156, 154 and 150.

Bores 190 are formed in portion 160 to accommodate respective pins 110.Bores 196 are formed in main cylindrical portion 156 to accommodaterespective pins 116 and bore 198 is formed in portion 166 to accommodatepin 122, which extends partly into bore 180 and thus engages axiallyextending slot 124 in driver assembly 106.

Reference is now additionally made to FIGS. 5A-5C, which illustrate thearm elements 108. As seen particularly in FIGS. 5A-5C, each arm element108 is a generally planar element including a rearward portion 200 of afirst, relatively greater thickness and a forward portion 202 of asecond, relatively lesser thickness.

The rearward portion includes a rearwardly-disposed transverselyextending bore 204 which accommodates pin 110 and cutout 118. Rearwardportion includes an outer-facing edge surface 206 and a partially curvedinward-facing edge surface 208.

Forward portion 202 includes a forwardmost finger portion 210 having acollar engagement edge surface 212 and a forward disposed, inward-facingedge surface 214 which extends rearwardly to a shoulder 216, rearward ofwhich is a rearward disposed, inward-facing edge surface 218. Extendingrearwardly of collar engagement edge surface 212 is partially curvedoutward-facing edge surface 220.

Reference is now additionally made to FIGS. 6A-6F, which illustrateaxially driven collar engagement element 120. As seen in FIGS. 6A-6F,the collar engagement element 120 is a generally cylindrical symmetricelement having a rearwardly-disposed hub 230 from which four collarengagement vanes 232, distributed about the circumference of hub 230,extend axially forward.

Hub 230 defines a rearward-facing wall portion 234 having formed thereinan axial recess 236, which accommodates generally cylindrical rodportion 130. Forwardly of rearward-facing wall portion 234 there isprovided a transverse slot 238, which accommodates quick releaseconnector portion 134 and separates rearward-facing wall portion 234from a rearward facing surface 240 of an intermediate wall portion 242,having formed therein a recess 244, arranged and configured toaccommodate spring loaded ball engagement assembly 140. When quickrelease connector portion 134 is inserted in transverse slot 238, edgesurface 138 of cut out 136 is preferably aligned with or locatedradially interior of a corresponding edge surface 246 of intermediatewall portion 242, which is preferably at the same radial separation fromaxis 104 and other corresponding edge surfaces 248 of intermediate wallportion 242 lying intermediate vanes 232.

Preferably a pad 250 formed of a resilient material is attached to aforward facing surface 252 of intermediate wall portion 242. Pad 250typically engages a forward end of an endoscope and is provided toprotect that forward end against impact damage.

Collar engagement vanes 232 preferably have a generally roundedforward-facing edge surface 260 and a somewhat rounded outer-facingcollar engagement surface 262 as well as a somewhat rounded inner-facingendoscope engagement surface 264.

In accordance with a preferred embodiment of the present invention,vanes 232 have a length of approximately 16.5 mm and a width ofapproximately 6.5 mm, and the thickness of pad 250 is approximately 1.5mm. According to a yet preferred embodiment of the present invention,the distance between inner-facing endoscope engagement surfaces 264 ofopposing vanes 232 is approximately 14 mm, thereby allowing theinsertion therebetween of endoscopes having any diameter of up toapproximately 13 mm without causing damage to the endoscope.

It is appreciated that any suitable number of vanes 232 may be employed.Accordingly, it is appreciated that any suitable number of arm elements108 may be employed. Specifically, three vanes 232 and three armelements 108 may be employed.

Reference is now made to FIGS. 7A, 7B, 7C, 7D, 7E, 7F, 7G, 7H, 7I, 7J,7K, 7L, 7M, 7N, 7O, 7P and 7Q, which are simplified illustrations ofvarious stages in the operation of the device of FIGS. 1 & 2 formounting an auxiliary endoscope assembly onto an endoscope, and ofvarious stages in the operation of a collar cutting tool for cutting acollar of an auxiliary endoscope assembly mounted on an endoscope; andto FIGS. 8A, 8B, 8C, 8D, 8E, 8F, 8G, 8H, 8I, 8J, 8K, 8L, 8M, 8N, 8O and8P, which are sectional illustrations, taken along lines VIII-VIII inFIGS. 1 and 7A-7P in corresponding FIGS. 7A-7P.

As seen in FIGS. 7A-8P, the device 100 is employed to mount an auxiliaryendoscope assembly 300 (shown in FIGS. 7A-8P) onto an endoscope 302(shown in FIGS. 7J-7L, 7O-7Q, and 8J-8P). Endoscope 302 is preferably aconventional endoscope, such as a VSB-3430K video enteroscope or aEC-3470LK video colonoscope, which are connectable to an endoscopyconsole such as a console including a EPK-1000 video processor and aSONY LMD-2140MD medical grade flat panel LCD monitor, all commerciallyavailable from Pentax Europe GmbH, 104 Julius-Vosseler St., 22527Hamburg, Germany.

In the illustrated example, the auxiliary endoscope assembly iscommercially available from Smart Medical Systems Ltd. of Raanana,Israel under model designation NaviAid BGE and is described in PCTPublished Applications PCT/IL2005/000849, PCT/IL2007/000600 andPCT/IL2007/000832, the disclosures of which are hereby incorporated byreference. It is appreciated that device 100 may be employedalternatively to mount another type of assembly having a resilientcollar 304 onto an endoscope or other elongate element. Resilient collar304 has an axially outward facing circumferential edge 306.

Preferably, collar 304 is formed of a resilient, relatively stretchablematerial such as latex or stretchable silicone. Preferably, thedimensions of collar 304 in a relaxed state are length in the range of6-20 mm, inner diameter in the range of 6-10 mm, and thickness in therange of 1-2 mm. In accordance with a preferred embodiment of thepresent invention, collar 304 has a length of approximately 10 mm, aninner diameter of approximately 8 mm, and an outer diameter ofapproximately 11 mm.

Preferably, collar 304 is configured for tight and fixed mounting overendoscopes of various diameters. For example, a collar 304 having alength of 10 mm, inner and outer diameters of 8 and 11 mm respectivelyin a relaxed state, and an inner diameter of 23 mm in the maximallystretched state, is suitable for tight and fixed mounting on endoscopeshaving a diameter in the range of 9.8-13 mm.

FIGS. 7A and 8A show the device 100 and the auxiliary endoscope assembly300 prior to mutual engagement. Collar engagement element 120 is engagedby quick release connector portion 134. This engagement is maintained atleast partially by the engagement of spring loaded ball engagementassembly 140 with recess 244.

FIGS. 7B and 8B show a user holding the device 100 in one hand andholding the auxiliary endoscope assembly 300 in his other hand, with thecollar 304 facing the device 100. It is noted that at this stage thedriver assembly 106 is fully retracted with respect to thehand-engageable element 102. It is also noted that at this stage theuser's hand engages outer-facing edge surfaces 206 and 220 of armelements 108 and forces them, against the urging of springs 114,radially inwardly to a maximum possible degree such that collarengagement edge surfaces 212 of arm elements 108 define a generallynon-truncated cone and thus can enter collar 304 as seen in FIGS. 7C and8C and partially stretch the collar 304.

FIGS. 7D and 8D show collar engagement edge surfaces 212 partiallystretching collar 304, when the user's hands no longer force armelements 108 inwardly. Normally springs 114 are selected so that furtherstretching of collar 304 does not occur at this stage, as can be seenfrom a comparison of FIGS. 8C and 8D, which are identical.

FIGS. 7E and 8E show slight forward axial displacement of the driverassembly 106 relative to hand-engageable element 102. This forwarddisplacement causes collar engagement element 120 to move axiallyforward such that engagement between edge surface 246 and 248 of hub 230of collar engagement element 120 and corresponding inward-facing edgesurfaces 208 forces arm elements 108 to pivot radially outwardly aboutpins 110 in bores 190 in hand-engageable element 102, thus expanding thecone defined by collar engagement edge surfaces 212 of finger portions210 and further stretching collar 304.

FIGS. 7F and 8F show additional forward axial displacement of the driverassembly 106 relative to hand-engageable element 102. This additionalforward displacement causes collar engagement element 120 to moveaxially forward to an additional extent such that engagement betweenedge surface 246 and 248 of hub 230 of collar engagement element 120 andcorresponding inward-facing edge surfaces 218 forces arm elements 108 topivot radially further outwardly about pins 110 in bores 190 inhand-engageable element 102, thus additionally expanding the conedefined by collar engagement edge surfaces 212 of finger portions 210and even further stretching collar 304. This additional forwarddisplacement also causes forward portions of vanes 232 to be locatedinside collar 304 but not in touching engagement therewith.

FIGS. 7G and 8G show further forward axial displacement of the driverassembly 106 relative to hand-engageable element 102. This furtherforward displacement causes collar engagement element 120 to moveaxially forward to a further extent such that engagement between edgesurfaces 246 and 248 of hub 230 of collar engagement element 120 andcorresponding inward-facing edge surfaces 214, which are separated frominward-facing edge surfaces 218 by shoulders 216 and lie radiallyoutward with respect to surfaces 218, allows arm elements 108 to pivotradially inwardly about pins 110 in bores 190 in hand-engageable element102, under the urging of the collar element 304 in engagement withcollar engagement edge surfaces 212. This contracts the truncated conedefined by collar engagement edge surfaces 212 of finger portions 210allowing collar 304 to be stretched only by virtue of the touching andsupporting engagement of outer-facing collar engagement surfaces 262 ofvanes 232 with the interior of collar 304.

FIGS. 7H and 8H show maximum forward axial displacement of the driverassembly 106 relative to hand-engageable element 102. This maximumforward displacement causes collar engagement element 120 to moveaxially forward to a maximum extent limited by the engagement of pin 122with a rearward end of slot 124 in generally cylindrical rod portion 130such that finger portions 210 of arm elements 108 are no longer intouching engagement with the collar 304 and are retracted therefrom,thus allowing arm elements 108 to pivot radially outward about pins 110in bores 190 in hand-engageable element 102, under the urging of springs114.

FIGS. 7I and 8I show the collar 304 being stretched by engagement withvanes 232 of collar engagement element 120 and disengagement of thecollar engagement element 120 from the cylindrical rod portion 130.

FIGS. 7J and 8J show initial insertion of endoscope 302 into a lumen 320of the auxiliary endoscope assembly 300 from an end 322 of the auxiliaryendoscope assembly 300 opposite that at which collar 304 is located,while collar 304 is still being stretched by engagement with vanes 232of collar engagement element 120.

FIGS. 7K and 8K show full insertion of endoscope 302 into lumen 320 ofthe auxiliary endoscope assembly 300 such that a forward end 324 ofendoscope 302 engages pad 250 on collar engagement element 120.

FIGS. 7L and 8L show reengagement of the cylindrical rod portion 130with the collar engagement element 120, by insertion of quick releaseconnector portion 134 in slot 238 in collar engagement element 120. Thisengagement is maintained at least partially by the engagement of springloaded ball engagement assembly 140 with recess 244. At this stage thedriver assembly 106 is preferably in its fully forward position.

Reference is now specifically made to FIGS. 7M, 7N, 8M and 8N whichillustrate resilient outer tubular article disengagement functionalityoperative for disengagement of at least a portion of the resilient outertubular collar 304 from the collar engagement element 120.

FIGS. 7M and 8M show operation of initial retraction of the driverassembly 106 relative to the hand-engageable element 102 to a stagewhere forward-facing generally circular edge 152 touchingly engagesaxially outward facing edge 306 of collar 304.

FIGS. 7N and 8N show full retraction of the driver assembly 106 relativeto the hand-engageable element 102 to a stage where the vanes 232 ofcollar engagement element 120 are retracted and disengaged from theinterior of the collar 304. At this stage the resilient collar 304tightly hugs the end 324 of the endoscope 302.

It is appreciated that the structure of device 100 and the methodologydescribed hereinabove normally will position the end 324 of theendoscope 302 at the predetermined distance from the axially outwardfacing edge 306 of collar 304, which preferably depends on the length ofvanes 232. In accordance with a preferred embodiment of the presentinvention, vanes 232 have a length of approximately 16.5 mm and a widthof approximately 6.5 mm, and the thickness of pad 250 is approximately1.5 mm, thereby providing placement of a resilient collar 304 having alength of approximately 10 mm in a distance of approximately 2-5 mm fromthe forward edge of endoscope 302.

FIGS. 7O and 8O show an initial step in disengagement of the auxiliaryendoscope assembly 300 from endoscope 302. A collar cutting tool 330preferably having an elongate, tapered forward finger 332 and a collarcutting edge 334 is employed for this purpose. Forward finger 332preferably demonstrates maximum flexibility at a forward portion 336thereof and gradually increasing rigidity rearwardly thereof. Forwardfinger 332 is preferably formed of a material whose hardness is lowerthan that of an outer surface of endoscope 302, thereby to preventpossible damage thereto. FIGS. 7O and 8O show insertion of forwardportion 336 of the forward finger 332 between collar 304 and endoscope302, such that forward finger 332 functions as a spacer, spacing theendoscope 302 from the collar 304 and the cutting edge 334.

FIGS. 7P and 8P show a further step in disengagement of the auxiliaryendoscope assembly 300 from endoscope 302. Collar cutting edge 334 ofcollar cutting tool 330 engages outward facing edge 306 of collar 304,forming a cut 340 therein.

FIG. 7Q shows full slitting of collar 304 at cut 340, thus eliminatingthe previous hugging engagement of collar 304 and endoscope 302 (FIG.7N). At this stage, the auxiliary endoscope assembly 300 may be readilyslid off the endoscope 302.

Reference is now made to FIG. 9, which is a simplified, partially cutaway, pictorial illustration of a double balloon device 400, constructedand operative in accordance with a preferred embodiment of the presentinvention, which is suitable for mounting on a conventional endoscope.As seen in FIG. 9, the double balloon device comprises a forwardendoscope-mountable inflatable balloon assembly 402 and a rearwardendoscope-mountable inflatable balloon assembly 404 which areinterconnected by a flexible forward balloon inflation/deflation tube406.

Forward endoscope-mountable inflatable balloon assembly 402 preferablyincludes a generally flexible, preferably resilient tubular sleeve 408,preferably having a forward-facing resilient collar 410 integrallyformed therewith. Collar 410 may be similar to collar 304 describedhereinabove and may alternatively be separate from sleeve 408 andattached thereto as by an adhesive. It is appreciated that collar 410and sleeve 408, which are formed separately, may be formed of differentmaterials, or from similar materials but with different properties suchas strength, flexibility, stretchability and dimensions. For example,sleeve 408 may be formed of a highly flexible and stretchable siliconematerial, and collar 410 may be formed of a less flexible and lessstretchable silicone material having a higher expansion resistance.

Sleeve 408 is preferably cylindrical and is arranged about an axis 412and preferably has a main lumen 414 for accommodating an endoscope and aside lumen 416 for accommodating a forward portion 418 of flexibleforward balloon inflation/deflation tube 406. Side lumen 416 extendsalong part of the length of sleeve 408, forwardly from its rearwardfacing end and outwardly of main lumen 414 along a generally spiral pathwith respect to axis 412 and terminates in an open end 420. Preferablyforward portion 418 extends partially along and inside side lumen 416and is fixedly and sealingly attached thereto as by a suitable adhesive,so as to provide a sealed inflation/deflation pathway therewith.Typically sleeve 408 has a length of approximately 8-15 cm.

It is appreciated that sleeve 408 may be constructed of a flexible andstretchable material, such as flexible and stretchable silicon, latex orrubber, thereby enabling it to conform to bending of an endoscope ontowhich it is mounted. It is further appreciated that main lumen 414 ofsleeve 408 preferably has an untensioned inner circumference slightlylarger than the cross-sectional circumference of an endoscope beinginserted therethrough, thereby allowing it to be pulled and slid overthe endoscope during mounting thereof.

A forward inflatable balloon 430 is sealably mounted onto an outersurface of sleeve 408 and arranged with respect to side lumen 416 suchthat open end 420 of side lumen 416 lies interiorly thereof forproviding inflation and deflation thereof.

It is appreciated that in accordance with a preferred embodiment of thepresent invention balloon 430 is generally inflatable, and can beinflated to a diameter about 3-10 times larger than its diameter whennot inflated. In accordance with a preferred embodiment of the presentinvention, useful for small intestine endoscopy, the diameter of balloon430 when fully inflated is in the range of 35-45 mm. Preferably,inflation of balloon 430 to a diameter less than 45 mm may be achievedusing relatively low pressure, such as in the range of 20-40 millibars.

In another specific embodiment, useful for large intestine endoscopy,the diameter of balloon 430, when fully inflated, is in the range of 4-6centimeters. In a further embodiment, also useful for large intestineendoscopy, the diameter of balloon 430, when fully inflated, is sixcentimeters. Preferably, inflation of balloon 430 to a diameter lessthan six centimeters may be achieved using relatively low pressure, suchas in the range of 20-40 millibars.

It is appreciated that in accordance with a preferred embodiment of thepresent invention, useful for in vivo inspection of a generally tubularbody portion having a variable cross-sectional diameter, the expansiondiameter range of balloon 430, when mounted onto an endoscope, is largerthan the maximum cross-sectional diameter of the generally tubular bodyportion, thereby enabling engagement of expanded balloon 430 with theinterior surface of the generally tubular body portion, and anchoring ofthe endoscope thereto. Preferably, balloon 430 is a relatively soft,highly compliant balloon, operative to at least partially conform to theshape of the interior surface of the generally tubular body portion whenin engagement therewith.

It is appreciated that balloon 430 may be formed of suitable well-knownstretchable materials such as latex, flexible silicone, or highlyflexible nylon. Alternatively, balloon 430 may be formed ofpolyurethane, which is less stretchable and conforming than latex,flexible silicone or highly flexible nylon. Preferably, the diameter ofballoon 430 is sufficient to ensure tight anchoring at any part of thegenerally tubular body portion. Alternatively, balloon 430 may beobviated.

Rearward endoscope-mountable inflatable balloon assembly 404 preferablyincludes a generally non axially compressible, tubular sleeve 438.Sleeve 438 is preferably cylindrical and in use is arranged about axis412 and preferably has a main lumen 440 for accommodating an endoscopeand first and second side lumens 442 and 444.

First side lumen 442 accommodates a rearward portion 446 of flexibleforward balloon inflation/deflation tube 406. First side lumen 442extends along the length of sleeve 438, outwardly of main lumen 440along a generally spiral path with respect to axis 412. Preferablyrearward portion 446 extends partially along and inside a forward facingportion 448 of first side lumen 442 and is fixedly and sealinglyattached thereto as by a suitable adhesive, so as to provide a sealedinflation/deflation pathway therewith. A forward ballooninflation/deflation supply and exhaust tube 450 extends from a connector452 outside of assembly 404, partially along and inside a rearwardfacing portion 454 of first side lumen 442 and is fixedly and sealinglyattached thereto as by a suitable adhesive, so as to provide a sealedinflation/deflation pathway therewith.

Second side lumen 444 accommodates a forward portion 462 of a flexiblerearward balloon inflation/deflation supply and exhaust tube 464. Secondside lumen 444 extends along part of the length of sleeve 438, outwardlyof main lumen 440 along a generally spiral path with respect to axis 412from a rear edge of sleeve 438 to an open end 466. Rearward ballooninflation/deflation supply and exhaust tube 464 extends from a connector472 outside of assembly 404, partially along and inside a rearwardfacing portion 474 of second side lumen 444 and is fixedly and sealinglyattached thereto as by a suitable adhesive, so as to provide a sealedinflation/deflation pathway therewith.

A rearward inflatable balloon 480 is sealably mounted onto an outersurface of sleeve 438 and arranged with respect to second side lumen 444such that open end 466 of second side lumen 444 lies interiorly thereoffor providing inflation and deflation thereof. It is appreciated that inaccordance with a preferred embodiment of the present invention balloon480 is generally inflatable, and can be inflated to a diameter about3-10 times larger than its diameter when not inflated. In accordancewith a preferred embodiment of the present invention, useful for smallintestine endoscopy, the diameter of balloon 480 when fully inflated isin the range of 35-45 mm. Preferably, inflation of balloon 480 to adiameter less than 45 mm may be achieved using relatively low pressure,such as in the range of 20-40 millibars.

In another specific embodiment, useful for large intestine endoscopy,the diameter of balloon 480, when fully inflated, is in the range of 4-6centimeters. In a further embodiment, also useful for large intestineendoscopy, the diameter of balloon 480, when fully inflated, is sixcentimeters. Preferably, inflation of balloon 480 to a diameter lessthan six centimeters may be achieved using relatively low pressure, suchas in the range of 20-40 millibars.

It is appreciated that in accordance with a preferred embodiment of thepresent invention, useful for in vivo inspection of a generally tubularbody portion having a variable cross-sectional diameter, the expansiondiameter range of balloon 480, when mounted onto sleeve 438, is largerthan the maximum cross-sectional diameter of the generally tubular bodyportion, thereby enabling engagement of expanded balloon 480 with theinterior surface of the generally tubular body portion, and anchoring ofsleeve 438 thereto. Preferably, balloon 480 is a relatively soft, highlycompliant balloon, operative to at least partially conform to the shapeof the interior surface of the generally tubular body portion when inengagement therewith.

It is appreciated that balloon 480 may be formed of suitable well-knownstretchable materials such as latex, flexible silicone, or highlyflexible nylon. Alternatively, balloon 480 may be formed ofpolyurethane, which is less stretchable and conforming than latex,flexible silicone or highly flexible nylon. Preferably, the diameter ofballoon 480 is sufficient to ensure tight anchoring at any part of thegenerally tubular body portion. Alternatively, balloon 480 may beobviated.

Preferably a fiducial mark 482 is provided at a rearward end of sleeve438 to enable an operator to monitor and prevent undesired rotation oftube 438 about axis 412. Preferably, sleeve 438 is of a typical lengthof approximately 120-150 cm and has an inner diameter of approximately10-13.5 mm and an outer diameter of approximately 12-15.5 mm, so as tobe readily slidable over a conventional endoscope. Preferably, sleeve438 is configured for mounting over endoscopes of various diameters,such as in the range of 9.5-13 mm.

It is appreciated that sleeve 438 is relatively flexible, thereby beingable to conform to bending of the endoscope onto which it is slidablymounted, and is yet sufficiently rigid so as to allow its sliding overthe endoscope by pushing it forward at a rearward end thereof.

Sleeve 438 may be formed of any suitable material such as silicone,PEBAX®, PVC or polyurethane. In accordance with a preferred embodimentof the present invention, the inner surface of sleeve 438 is formed of alow-friction material, such as thin and flexible internal TEFLON® tubeor a hydrophilic coating, so as to allow low resistance sliding ofsleeve 438 over an endoscope in a bent orientation.

Reference is now made to FIG. 10, which is a simplified pictorialillustration of the double balloon device of FIG. 9, mounted on aconventional endoscope 490 forming part of a conventional endoscopesystem. Endoscope 490 may be identical to endoscope 302 describedhereinabove.

In practice, initially the rearward endoscope-mountable inflatableballoon assembly 404 is slid over a forward end 492 of endoscope 490 inthe manner of a conventional overtube. Thereafter the forwardendoscope-mountable inflatable balloon assembly 402 is fitted onto theendoscope with collar 410 being snugly mounted adjacent the forward end492 of endoscope 490 preferably by using the device 100 describedhereinabove with reference to FIGS. 1-7N and 8A-8N.

Operation of the double balloon device 400 may be identical or similarto that of a commercially available double-balloon endoscope, such as adouble balloon endoscope assembly including EN-450T5 enteroscope,TS-13140 overtube and BS-2 front balloon, which interface with balloonpump control BP-20 and 2200 video system, all commercially availablefrom Fujinon Inc., of 10 High Point Drive, Wayne, N.J., USA.

Disengagement of the double balloon device 400 from endoscope 490following use, may be readily achieved by using the collar cutting tool330 described hereinabove with reference to FIGS. 7O-7Q and 8O-8P.

Reference is now made to FIGS. 11A & 11B, which are simplified pictorialillustrations of an endoscope overtube constructed and operative inaccordance with a preferred embodiment of the present invention inrespective open and closed orientations; FIG. 12, which is a simplifiedexploded pictorial illustration of the endoscope overtube of FIGS. 11A &11B and FIGS. 13A, 13B & 13C, which are respective simplified pictorial,end view and side view illustrations of a balloon employed in theendoscope overtube of FIGS. 11A-12.

As seen in FIGS. 11A-12, there is provided an endoscope overtube 500constructed and operative in accordance with a preferred embodiment ofthe present invention including a generally non axially compressible,tubular generally cylindrical sleeve 502 arranged about a longitudinalaxis 504. Sleeve 502 is preferably slit axially, as indicated byreference numeral 506, thus defining axial slit edges 508 and 510 andthus is circumferentially expandable and compressible. A selectablyinflatable/deflatable balloon 520 is mounted over part of an outersurface 522 of sleeve 502.

Sleeve 502 preferably has a main lumen 528 for accommodating anendoscope 530, which may be similar to endoscope 302 describedhereinabove, and first and second side lumens 532 and 534 which arecircumferentially spaced from each other along outer surface 522 ofsleeve 502.

First side lumen 532 accommodates a forward portion 536 of a flexibleballoon inflation/deflation tube 540 and extends partially along thelength of sleeve 502, outwardly of main lumen 528, to an opening 542underlying and in fluid communication with the interior of balloon 520.Preferably, flexible tube 540 extends from a connector 544 outside ofsleeve 502 and forward portion 536 thereof extends partially along andinside a rearward-facing portion 546 of first side lumen 532 and isfixedly and sealingly attached thereto as by a suitable adhesive, so asto provide a sealed inflation/deflation pathway therewith.

Second side lumen 534 accommodates a forward portion 548 of a flexibleinstrument channel tube 550 which extends from a tool insertion port 552outside of sleeve 502. Second side lumen 534 extends along the entirelength of sleeve 502, along outer surface 522 thereof and underlyingballoon 520 from a rear edge of sleeve 502 to an open end 554.Instrument channel tube 550 extends from port 552, partially along andinside a rearward facing portion 556 of second side lumen 534 and isfixedly attached thereto as by a suitable adhesive.

Balloon 520 is preferably a preformed, flexible element, having agenerally cylindrical configuration when assembled onto sleeve 502 andsecurely mounted onto endoscope 530 (FIG. 11B). Balloon 520 includesperipheral sealing surfaces which are preferably adhesively joined orheat welded onto outer surface 522 of sleeve 502. The peripheral sealingsurfaces preferably include respective forward and rearwardcircumferential collar sealing surfaces 560 and 562 and first and secondaxial sealing surfaces 564 and 566 which extend parallel to slit edges508 and 510.

It is appreciated that the generally axial slit 506 of sleeve 502 may bestraight or curved, such as a straight slit parallel to longitudinalaxis 504, a spiral slit along longitudinal axis 504, or a sinusoidalslit. The forward edge of sleeve 502 is preferably smooth and rounded soas to avoid damage to tissue under examination during in vivo inspectionof a generally tubular body portion such as the intestine.

Preferably, sleeve 502 is of a typical length of approximately 100-160cm and has an inner diameter of approximately 10-13.5 mm and an outerdiameter of approximately 12-15.5 mm, so as to be readily slidable overa conventional endoscope. Preferably, sleeve 502 is configured formounting over endoscopes of various diameters, such as in the range of9.5-13 min. Yet preferably, the thickness of sleeve 502 is in the rangeof 0.3-2 mm, and may be constant or varying along its length.

In accordance with a preferred embodiment of the present invention, theforward portion of sleeve 502 underlying balloon 520 is relativelyrigid, thereby not allowing inward expansion of sleeve 502 duringinflation of balloon 520, so as to allow slidable motion of endoscope530 through sleeve 502 when balloon 520 is inflated. Alternatively, theforward portion of sleeve 502 underlying balloon 520 is highly flexible,thereby allowing inward expansion of sleeve 502 during inflation ofballoon 520, so as to engage endoscope 530 and fix its position relativeto sleeve 502 when balloon 520 is inflated, thereby preventing slidablemotion therebetween.

It is appreciated that sleeve 502 is relatively flexible, thereby beingable to conform to bending of endoscope 530 onto which it is slidablymounted, and is yet sufficiently rigid so as to allow its sliding overendoscope 530 by pushing it forward at a rearward end thereof. Sleeve502 may be formed of any suitable material such as silicone, PEBAX®, PVCor polyurethane. In accordance with a preferred embodiment of thepresent invention, the inner surface of sleeve 502 is formed of alow-friction material, such as thin and flexible internal TEFLON® tubeor a hydrophilic coating, so as to allow low resistance sliding ofsleeve 502 over an endoscope in a bent orientation.

It is appreciated that in accordance with a preferred embodiment of thepresent invention balloon 520 is generally inflatable, and can beinflated to a diameter about 3-10 times larger than its diameter whennot inflated. In accordance with a preferred embodiment of the presentinvention, useful for small intestine endoscopy, the diameter of balloon520 when fully inflated is in the range of 35-45 mm. Preferably,inflation of balloon 520 to a diameter less than 45 mm may be achievedusing relatively low pressure, such as in the range of 20-40 millibars.

In another specific embodiment, useful for large intestine endoscopy,the diameter of balloon 520, when fully inflated, is in the range of 4-6centimeters. In a further embodiment, also useful for large intestineendoscopy, the diameter of balloon 520, when fully inflated, is sixcentimeters. Preferably, inflation of balloon 520 to a diameter lessthan six centimeters may be achieved using relatively low pressure, suchas in the range of 20-40 millibars.

It is appreciated that in accordance with a preferred embodiment of thepresent invention, useful for in vivo inspection of a generally tubularbody portion having a variable cross-sectional diameter, the expansiondiameter range of balloon 520, when mounted onto sleeve 502, is largerthan the maximum cross-sectional diameter of the generally tubular bodyportion, thereby enabling engagement of expanded balloon 520 with theinterior surface of the generally tubular body portion, and anchoring ofsleeve 502 thereto. Preferably, balloon 520 is a relatively soft, highlycompliant balloon, operative to at least partially conform to the shapeof the interior surface of the generally tubular body portion when inengagement therewith.

It is appreciated that balloon 520 may be formed of suitable well-knownstretchable materials such as latex, flexible silicone, or highlyflexible nylon. Alternatively, balloon 520 may be formed ofpolyurethane, which is less stretchable and conforming than latex,flexible silicone or highly flexible nylon. Preferably, the diameter ofballoon 520 is sufficient to ensure tight anchoring at any part of thegenerally tubular body portion. Alternatively, balloon 520 may beobviated. A plurality of latches 570 are provided for selectablysecurely mounting overtube 500 onto endoscope 530 and are distributedalong the length of overtube 500 other than underlying balloon 520.These latches preferably each include an arm portion 572, which isjoined at one end 574 thereof, to outer surface 522 of sleeve 502adjacent one of edges 508 and 510 of slit 506 as by adhesive or heatwelding. At an opposite end 576 of each arm there is provided a firstattachment portion 578 which removably engages a corresponding secondattachment portion 580 mounted adjacent an opposite one of edges 508 and510. In the illustrated embodiment, the arm portions 572 are attachedadjacent edges 508 and the first attachment portion 578 is a recesswhich mates with a corresponding protrusion defining the secondattachment portion 580. Any other suitable arrangement may be employed.

Reference is now made to FIGS. 14A, 14B, 14C, 14D and 14E, which aresimplified illustrations of association of the endoscope overtube ofFIGS. 11A-12 with a conventional endoscope and a conventional endoscopetool.

FIG. 14A shows the overtube 500 of FIGS. 11A-12 about to be mounted onan endoscope 530 forming part of a conventional endoscope system. Theendoscope system may comprise, for example, a conventional endoscopesuch as a VSB-3430K video enteroscope or a EC-3470LK video colonoscope,which are connectable to an endoscopy console such as a consoleincluding a EPK-1000 video processor and a SONY LMD-2140MD medical gradeflat panel LCD monitor, all commercially available from Pentax EuropeGmbH, 104 Julius-Vosseler St., 22527 Hamburg, Germany. It is seen that aforward part of overtube 500 is in an expanded open orientation suchthat slit 506 can accommodate the thickness of endoscope 530.

FIG. 14B shows a most forward part of overtube 500, including part ofballoon 520, latched in secure engagement with endoscope 530. FIG. 14Cshows more of overtube 500, including all of balloon 520, latched insecure engagement with endoscope 530. FIG. 14D shows all of overtube500, latched in secure engagement with endoscope 530. FIG. 14Eillustrates the general configuration of balloon 520 when inflated andthe insertion of a conventional endoscope tool through the instrumentchannel, defined by port 552, tube 550 and second side lumen 534, whichis preferably a low friction lumen comprising a flexible internalTEFLON® tube, a hydrophilic coating, or any alternative suitable lowfriction lumen.

It will be appreciated by persons skilled in the art that the presentinvention is not limited by what has been particularly shown anddescribed herein above. Rather the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove as well as variations and modifications whichwould occur to persons skilled in the art upon reading thespecifications and which are not in the prior art.

What is claimed is:
 1. A double-balloon auxiliary endoscope assemblysuitable for use with a conventional endoscope, said assemblycomprising: a forward balloon subassembly comprising: a forward balloonsupport sleeve arranged for mounting in a fixed position over saidconventional endoscope and having a forward balloon support sleevemounted, forward balloon inflation lumen extending at least partiallyalong said forward balloon support sleeve; and a forward balloon mountedon said forward balloon support sleeve and together therewith defining aforward inflatable volume which is inflatable via said forward balloonsupport sleeve mounted, forward balloon inflation lumen; an overtubesubassembly comprising: an overtube sleeve arranged for slidablemounting over said conventional endoscope; and an overtube balloonmounted on said overtube sleeve and together therewith defining arearward inflatable volume, and said overtube sleeve having first andsecond lumens extending at least partially therealong, said first lumenbeing an overtube mounted, forward balloon inflation lumen, and saidsecond lumen being an overtube mounted, overtube balloon inflationlumen, said rearward inflatable volume being inflatable via saidovertube mounted, overtube balloon inflation lumen; and an overtuberearward displacement accommodating, flexible interconnection tubeinterconnecting said forward balloon support sleeve mounted, forwardballoon inflation lumen and said overtube mounted, forward ballooninflation lumen.
 2. A double-balloon auxiliary endoscope assemblyaccording to claim 1 and wherein said interconnection tube is selectablyextendible by being at least partially straightened.
 3. A double-balloonauxiliary endoscope assembly according to claim 1 and also comprising aforward balloon inflation/deflation supply and exhaust tube connected tosaid first lumen and an overtube balloon inflation/deflation supply andexhaust tube connected to said second lumen.
 4. A double-balloonauxiliary endoscope assembly according to claim 1 and wherein saidforward balloon support sleeve includes a resilient collar.
 5. Adouble-balloon auxiliary endoscope assembly according to claim 1 andwherein said forward balloon support sleeve includes a collar which isadapted to fixedly mount said forward balloon support sleeve ontoendoscopes of varying outer diameter.
 6. A method for mounting adouble-balloon auxiliary endoscope assembly over a conventionalendoscope, the method comprising: sliding an overtube subassembly oversaid conventional endoscope; and thereafter sliding over saidconventional endoscope, while connected to said overtube subassembly viaa flexible interconnection tube, a forward balloon support sleeve of aforward balloon subassembly also including a forward balloon fixedlymounted on said forward balloon support sleeve and defining togethertherewith a forward inflatable volume.
 7. A method for mounting adouble-balloon auxiliary endoscope assembly over a conventionalendoscope according to claim 6 and also comprising: fixedly andremovably mounting said forward balloon support sleeve onto saidconventional endoscope.
 8. A method for mounting a double-balloonauxiliary endoscope assembly over a conventional endoscope according toclaim 6 and also comprising initially stretching and then releasing aresilient collar associated with said forward balloon support sleeve forfixedly and removably mounting of said forward balloon support sleeveonto said conventional endoscope.